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Reusable Instruments
EUDAMEDFDA UDIClass I (EU MDR)
Ref I-WI-3M-SRef I-X-RINGRef ZYG-TR-55-35Ref LISARef ZYG-TR-55-52Ref CH-I-DGRef I-CS-HDRef I-WI-3M-MRef I-IMP-INS-2Ref I-ZYG-INS-2Ref I-WI-3M-LRef ZYG-TR-55-45Ref I-HD-M
Identity
- Trade Name
- NA FDA UDIN/A FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDIDental implantation depth/angle gauge, reusable FDA UDIDental implant holding endpiece, reusable FDA UDI
- Device Name
- Reusable Instruments EUDAMEDInstrument, 1.22mm Hex Driver, Medium FDA UDIInstrument, Try-In Implant, Zygomatic 55° x 52 mm FDA UDIInstrument Zyg Z Depth Gauge FDA UDIInstrument, Try-In Implant, Zygomatic 55° x 45mm FDA UDIInstrument, Zygomatic Implant Inserter, Hex FDA UDIInstrument, Implant Inserter, Hex FDA UDIInstrument, 0.9mm Hex Driver FDA UDIInstrument, Try-In Implant, Zygomatic 55° x 35mm FDA UDIInstrument, Retention Ring for Connector to Handpiece FDA UDI
- Model / Reference
- I-WI-3M-S EUDAMEDI-X-RING EUDAMEDFDA UDIZYG-TR-55-35 EUDAMEDFDA UDILISA EUDAMEDZYG-TR-55-52 EUDAMEDFDA UDICH-I-DG EUDAMEDFDA UDII-CS-HD EUDAMEDFDA UDII-WI-3M-M EUDAMEDI-IMP-INS-2 EUDAMEDFDA UDII-ZYG-INS-2 EUDAMEDFDA UDII-WI-3M-L EUDAMEDZYG-TR-55-45 EUDAMEDFDA UDII-HD-M EUDAMEDFDA UDI
- Description
- Instrument, 1.22mm Hex Driver, Medium FDA UDIInstrument, Try-In Implant, Zygomatic 55° x 52 mm FDA UDIInstrument Zyg Z Depth Gauge FDA UDIInstrument, Try-In Implant, Zygomatic 55° x 45mm FDA UDIInstrument, Zygomatic Implant Inserter, Hex FDA UDIInstrument, Implant Inserter, Hex FDA UDIInstrument, 0.9mm Hex Driver FDA UDIInstrument, Try-In Implant, Zygomatic 55° x 35mm FDA UDIInstrument, Retention Ring for Connector to Handpiece FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06009544038634 EUDAMED06009544015260 EUDAMEDFDA UDI06009544023814 EUDAMEDFDA UDI06009544045267 EUDAMED06009544035398 EUDAMEDFDA UDI06009544036845 EUDAMEDFDA UDI06009544010609 EUDAMEDFDA UDI06009544038641 EUDAMED06009544012078 EUDAMEDFDA UDI06009544031789 EUDAMEDFDA UDI06009544038658 EUDAMED06009544023821 EUDAMEDFDA UDI06009544011392 EUDAMEDFDA UDI
- Basic UDI-DI
- 6009544038769E EUDAMED
- Direct Marketing DI
- 06009544038634 EUDAMED06009544015260 EUDAMED06009544023814 EUDAMED06009544045267 EUDAMED06009544035398 EUDAMED06009544036845 EUDAMED06009544010609 EUDAMED06009544038641 EUDAMED06009544012078 EUDAMED06009544031789 EUDAMED06009544038658 EUDAMED06009544023821 EUDAMED06009544011392 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMEDL26 SURGICAL SCREWDRIVERS, REUSABLE EUDAMED
- GMDN Term
- Surgical screwdriver, reusable FDA UDIDental implantation depth/angle gauge, reusable FDA UDIDental implant holding endpiece, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Portugal EUDAMEDGermany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDIFDA UDI
Moist Heat or Steam Sterilization FDA UDI
Reusable Instruments by Southern Implants (pty) Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6009544038769E | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Southern Implants (Pty) Ltd
- EUDAMED SRN
- ZA-MF-000035362
- Authorised Representative
- Southern Implants Europe AB SE-AR-000032508
Sources (31)
- EUDAMED e7984a8d-c17b-46de-b750-dd1fedcaba2b 61 fields · synced Sep 17, 2026
- EUDAMED f2410ea2-95e8-450d-bad8-333c49d70c80 61 fields · synced May 17, 2026
- EUDAMED c5928cbf-6e3d-4755-b2dc-25ae9a0563c0 61 fields · synced May 17, 2026
- EUDAMED 33a4bfaf-0e0b-4c92-bc33-d4305e7cf797 61 fields · synced May 17, 2026
- EUDAMED 46843116-2d54-44fa-b8fa-3c1325170867 61 fields · synced May 17, 2026
- EUDAMED d221330c-ff7e-48cd-8da3-db8cc0e45520 61 fields · synced May 17, 2026
- EUDAMED 65ae01e1-b125-434f-b524-cc42f5e00244 61 fields · synced May 18, 2026
- EUDAMED 27a43e58-d45b-4458-a213-9f311dca82c8 61 fields · synced May 18, 2026
- EUDAMED be645556-a800-484d-8514-485a4f7d22a1 61 fields · synced May 18, 2026
- EUDAMED 360aeb04-e5a6-409d-9999-36ac069ff505 61 fields · synced May 18, 2026
- EUDAMED 15dd5cb8-7c74-4454-bdd8-13adf08bb254 61 fields · synced May 18, 2026
- EUDAMED 102f9e27-8bd1-4cb0-badc-85a19272038e 61 fields · synced May 19, 2026
- EUDAMED 33b76ecc-c58f-4914-b569-eae352cbd93d 61 fields · synced May 19, 2026
- FDA UDI 6da07371-0e38-4211-ad32-123b55b288a1 33 fields · synced May 22, 2026
- FDA UDI 55cb4c8e-e2b1-41d7-8217-d9ca88f73148 33 fields · synced May 24, 2026
- FDA UDI e982597e-1f16-43c1-a257-4078f42dd265 33 fields · synced May 29, 2026
- FDA UDI 6bbb0163-8afe-4c4e-ada6-f7e756a1f38d 33 fields · synced May 29, 2026
- FDA UDI a74d9a72-1967-46d7-9a0b-2013d2d67635 33 fields · synced May 30, 2026
- FDA UDI 91124bb7-54a4-41e5-b2eb-4bd02350ed4b 33 fields · synced May 30, 2026
- FDA UDI e2b98ce7-9081-4285-bee2-c2320b9e8dbd 33 fields · synced May 30, 2026
- FDA UDI 1db65446-b1f5-4f38-a45e-ef62b21d1df4 33 fields · synced May 30, 2026
- FDA UDI fbe7bf43-7dc5-4b91-bba1-3a67a4834462 33 fields · synced May 30, 2026
- EUDAMED d9c09712-2369-4871-bc71-a2d9dfc8adce 61 fields · synced Jul 10, 2026
- EUDAMED e4af62b0-91fd-48f1-aea8-2d8eeb30c464 61 fields · synced Jul 10, 2026
- EUDAMED 88281edf-a27f-4710-8d14-87087a4e6cb0 61 fields · synced Jul 10, 2026
- EUDAMED cb92521e-3817-4bef-aed8-33784ce07d59 61 fields · synced Jul 13, 2026
- EUDAMED e17d27f4-c5a4-44e3-8be4-1cd66388761c 61 fields · synced Jul 15, 2026
- EUDAMED 2e5e5f17-64c3-41ef-91d2-1e087282cab4 61 fields · synced Jul 15, 2026
- EUDAMED af98920d-8e6c-44b6-a2fd-f3cad866fd1a 61 fields · synced Jul 16, 2026
- EUDAMED 6f005655-1e75-4101-8a3d-5df1ba69ec54 61 fields · synced Aug 4, 2026
- EUDAMED 2ef35bce-866c-4f38-84eb-d02007a79e45 61 fields · synced Sep 17, 2026